Latest From Elizabeth Orr
Edwards Lifesciences is paying Abbott Laboratories to settle disputes over patents on transcatheter mitral and tricuspid repair products.
Draft guidance from the US FDA updates the agency’s recommendations around research to support new devices for the treatment of prostate enlargement.
Medical device companies – including Sientra, Endologix and Invacare – won loans from the US government’s Paycheck Protection Program, intended to protect jobs during the coronavirus pandemic. In total, nearly 1,400 device makers collected as much as $1.6bn, according to a Medtech Insight analysis of PPP data.
The US FDA released five device-related close-out letters in June. An additional close-out letter, dated February 2017, was published for the first time recently due to an agency oversight.
The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.
Medical supplies distributor eSutures is facing a federal injunction over allegations the vendor sold counterfeit surgical supplies purportedly made by Johnson & Johnson unit Ethicon.